Application 019058

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENORMIN	ATENOLOL	INJECTABLE;INJECTION	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019058-001	TENORMIN	ATENOLOL	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1989-09-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	82100fc8-5a5a-4d80-8101-72024ee0abef	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
atenolol	ATENOLOL	direct rx	b3c757de-1cbf-61f5-e053-2995a90accfc	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	b6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	d21f2b4d-6584-48e5-8045-e5927ba03329	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Mylan Pharmaceuticals Inc.	a7048c81-6769-436b-8397-fbaa7489fcdf	2026-02-15	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	d7a93c64-0c52-4d72-a9be-37c7ca355cdf	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Ipca Laboratories Limited	98d29958-b026-4888-a516-7bb85bb7d479	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	43acd912-f0f4-47eb-b81f-cbbfed77c557	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	e4ece8f4-3714-42ba-b36d-d00586dfd33a	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	f31b11ed-2ff6-5cfc-e053-2a95a90af2ca	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	f318707a-4fb9-604c-e053-2a95a90ae973	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	f76d03b8-f8d6-59b8-e053-6394a90a3a3f	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	db5bd8e2-1314-0f7f-e053-2995a90ae86e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	d9cdc2ed-99bf-0d6a-e053-2a95a90a0262	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Northwind Health Company, LLC	f2b335b4-93d2-0459-e053-2a95a90a1a5b	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	QPharma, Inc.	bd43e0b1-c05e-01ae-e053-2a95a90af1cd	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	QPharma, Inc.	70d7a585-7a46-4eac-b2b5-2ac5b98d9882	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	QPharma Inc	f682a775-2255-05e2-e053-2a95a90ac3f3	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	331128cc-f56e-4329-e063-6394a90a5ead	2025-11-04	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	410c48ae-582a-2ab2-e063-6294a90af27c	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1223	SUPPL	2005-02-11
16185	SUPPL	2003-11-13
1222	SUPPL	2003-01-22
40872	SUPPL	2001-06-04
40871	SUPPL	2001-06-04